Introduction: Pancreatic cancer is one of the most aggressive malignancies with only 5% of patients being alive at five years. EUS (endoscopic ultra sound) is an established, sensitive diagnostic tool in pancreatic cancer and for staging purposes. Additionally, EUS enables guided fine needle aspiration (FNA), which is currently recommended as the first-line procedure whenever a pathological diagnosis is required. However, EUS-FNA as a sampling method has its drawbacks, due to a relatively low negative predictive value. Confocal laser endomicroscopy has emerged in recent years as a novel method that enables in vivo microscopic analysis during ongoing endoscopy. Recently, confocal laser endomicroscopy has gone beyond the superficial luminal indications with the development of a new microprobe, i.e. a flexible laser probe (nCLE) that can pass through a 19-gauge needle. Combined with EUS, descriptive criteria for the diagnosis of pancreatic cystic neoplasm has been developed in a multicentre trial. However, only a limited number of cases of solid pancreatic masses have been described with nCLE.

Aim and Method: To describe confocal imaging criteria for pancreatic masses, lymph nodes or liver metastases identified during EUS procedures performed for pancreatic cancer staging (EUS-nCLE), while evaluating also the feasibility and safety of nCLE examination. The hypothesis is that EUS-nCLE could allow targeted tissue sampling of pancreatic lesions resulting in more accurate diagnosis. XX patients were included all presenting with a clinical suspicion of pancreatic cancer or imaging studies showing a pancreatic mass. During the procedure an nCLE preloaded 19G FNA needle was advanced into the lesion under EUS guidance. A contrast agent was administered intravenously (2.5 ml fluorescein 10%). The data was stored digitally for post procedural analysis. Afterwards EUS-FNA was performed for cytology smears to enable a final pathological diagnosis. Correlations between the nCLE images and the conventional pathology were identified.

EUS-nCLE will be performed after EUS identification of the pancreatic tumor / lymph node / liver metastasis:

Confocal images will be analyzed to correlate representative confocal images and classical hematoxylin and eosin sections.

The final diagnosis will be based on EUS-FNA cytology and/or histological specimens in those patients that will be further referred for surgery. For the patients without positive cytology or histology the diagnosis will be based on EUS tumor characteristics and other relevant information (clinical, imaging tests) with follow-up for at least six months

The outcome is fully descriptive.

Secondary Outcome Measures:

Safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Number of adverse events related til the procedure

Feasibility [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Feasibility of nCLE examination measured by the number of patients, where nCLE is accomplished

The study will prospectively include patients referred to our department for EUS and EUS-FNA of suspected pancreatic masses during a 12 months period. The indication for this investigation will be based on the patient's clinical history and previous imaging studies (abdominal ultrasound, CT scan, MRI).

Device: needle based CLE

EUS-nCLE will be performed after EUS identification of the pancreatic tumor / lymph node / liver metastasis:

The confocal microprobe will be preloaded in a 19G FNA needle as previously described and advanced into the lesion under EUS guidance.

nCLE examination will follow after the intravenous administration of the contrast agent (2.5 ml fluorescein 10%).

Image data will be stored digitally for offline analysis.

Other Name: nCLE

Procedure: EUS-FNA

Endoscopic ultrasound (EUS) is an established tool in pancreatic masses used both for diagnosis, but also for staging purposes. Additionally, EUS enables guided fine needle aspiration (FNA), which is currently recommended as the first-line procedure whenever a pathological diagnosis is required.

Patients diagnosed with solid pancreatic masses with an indication for EUS-FNA

Signed informed consent for EUS with FNA and nCLE examination

Exclusion criteria

Failure to provide informed consent

Patients with a contraindication for EUS-FNA

Known allergy to fluorescein

Pregnant or breast-feeding patients

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01734967